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On January 24, 2025, the European Commission published an updated version of the Manual of The Working Group on Cosmetic Products (Sub-group on Borderline Products) on the Scope of Application of the Cosmetics Regulation (EC) No 1223/2009 (Art. 2(1)(A)) (Borderline Manual). This updated version includes a dedicated section discussing whether products in vials or ampoules qualify as cosmetic products.1
The Regulation (EC) No 1223/2009 (Cosmetics Regulation) establishes criteria for defining a cosmetic product, including the product nature, the application site, and the intended purpose. However, certain products, referred to as "borderline products", present challenges in classification, as it may be unclear whether they fall under the scope of the Cosmetics Regulation or other sectoral regulations. To provide clarity on such cases, the Commission has developed and maintains the Borderline Manual.
Compared to the February 2024 version, the updated Borderline Manual adds a new section, "3.3.34. Products in a Vial or Ampoule", which offers specific guidance on determining whether these products meet the criteria for classification as cosmetics under the Cosmetics Regulation. According to this new section, substances or mixtures in vials or ampoules intended for injection are excluded from the definition of cosmetics. For such products to qualify as cosmetics, they should:
Serve a cosmetic function (e.g., cleaning, perfuming, or correcting body odors of the external parts of the human body);
Be intended exclusively for external use, with clear labelling and usage instructions specifying external application;
Be presented in a way that avoids ambiguity, preventing confusion with medicinal products or medical devices;
Not be marketed with a device that could allow the injection of this product, or its delivery below the epidermis.
Furthermore, the updated Borderline Manual emphasizes that national competent authorities are responsible for determining the product qualification on a case-by-case basis. This decision should be made based on factors such as the product's presentation, usage instruction, intended function, ingredients, mode of action, and how it is promoted across various channels.
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